Keynote Trials for Melanoma

As the sponsor of the Keynote Oncology Clinical Trials, Merck is passionate about improving health. We are committed to accelerating every step in the journey in our quest to bring treatment options to people with cancer.

Below are trials currently being conducted in melanoma, evaluating the investigational study drug, pembrolizumab (MK-3475).

Active Clinical Trials

The cancer types listed below currently have active trial listings on Click on a study name to be directed to that trial's information, or call 1-888-577-8839 to find a study site near you for the trial you are interested in.

Advanced Melanoma Keynote Study

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (P08719/KEYNOTE-002)

This study is being done to compare survival using pembrolizumab (MK-3475) or standard chemotherapy for participants with advanced melanoma (MEL) who have progressed after prior therapy. Participants will be randomized to receive either low dose pembrolizumab, higher dose pembrolizumab or Investigator-choice chemotherapy. The pembrolizumab dose will be blinded to Investigators and participants. The randomization to either pembrolizumab or Investigator choice chemotherapy will be conducted in open-label fashion. The four standard chemotherapy choices are carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. Participants on standard chemotherapy who experience disease progression may be eligible to cross-over to treatment with pembrolizumab provided they meet protocol-specified requirements for cross-over.

more about the study
Clinical Trial for Melanoma

Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006)

This is a three-arm study to evaluate the safety and efficacy of two dosing schedules of pembrolizumab (MK-3475) compared to ipilimumab for the treatment of ipilimumab-naïve participants with unresectable or metastatic melanoma.

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Keynote Melanoma Study

A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Trametinib and Dabrafenib in Participants With Advanced Melanoma (MK-3475-022/KEYNOTE-022)

This is a 3-part dose-finding and preliminary efficacy study of pembrolizumab (Pembro) + dabrafenib (D) + trametinib (T) for participants with advanced melanoma. Parts 1 and 2 are open-label to find and confirm the maximum tolerated dose (MTD)/maximum administered dose (MAD) for Pembro+D+T. The primary hypothesis (Parts 1 and 2) is that Pembro+D+T is sufficiently well-tolerated to permit clinical investigation. Part 3 is a double-blind study of Pembro+D+T versus placebo+D+T. The primary study hypothesis (Part 3 only) is that the Pembro+D+T improves progression-free survival (PFS) compared with placebo+D+T. Parts 1 and 2 of the study will also explore the MTD/MAD for open-label Pembro+T (for v-raf murine sarcoma viral oncogene homolog B1 [BRAF] mutation-negative participants) concurrently with the Pembro+D+T arm; Pembro+D (for BRAF mutation-positive participants) may be initiated in Parts 1 and 2.

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MK-3475 Trial for MEL & RCC

Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alfa-2b and Pembrolizumab+ Ipilimumab in Participants with Advanced Melanoma or Renal Cell Carcinoma

This study is being done to analyze the safety, tolerability, and efficacy of treatment for advanced melanoma (MEL) and renal cell carcinoma (RCC) using combination regimens of pembrolizumab + pegylated interferon alfa-2b (PegIFN-2b) and pembrolizumab + ipilimumab (IPI). The primary hypothesis is that these combinations will be sufficiently well-tolerated to permit continued clinical investigation.

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MK-3475 Trial for Stage 3 Melanoma

Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/KEYNOTE-054)

This study will assess whether post-resection adjuvant therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo for high-risk participants with melanoma (Stage IIIA [> 1 mm metastasis], IIIB and IIIC). The study will also assess whether pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed cell death ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for stage of disease and region and then will be randomly assigned to receive either pembrolizumab or placebo.

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Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.